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Completed

NCT Number: NCT04630912

ACT for People With Dementia Experiencing Psychological Distress

Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Purpose: To investigate the effectiveness and acceptability of Acceptance and Commitment Therapy (ACT) for people with dementia, considering carer-supported, remote delivery and necessary therapy adaptations. Methods: A hermeneutic single case efficacy design (HSCED) series was used to analyse therapy process and change for three clients with dementia and psychological distress. Quantitative and qualitative data was collated ('rich case records') and analysed by three independent psychotherapy experts ('judges') who determined the outcome for each client. Results: Over the course of therapy, it was concluded that one client with dementia made positive changes, specifically reliable reductions in psychological distress, which were largely attributable to Acceptance and Commitment Therapy (ACT). Two clients remained unchanged. Discussion/Conclusion: Where change was achieved, the ACT-specific processes of values, committed action and acceptance, in combination with non-specific therapy factors including a strong client-carer relationship, existing client interests and individualised therapy adaptations, were facilitative of change. Hence, ACT may be feasible and effective by helping carers to better meet the needs of their loved ones with dementia. Future research to optimise ACT delivery in this population may be beneficial. Furthermore, the assessment of carer factors (e.g., their psychological flexibility, the client-carer relationship) may strengthen the evidence-base for systemic ACT-use.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Mental Health Team for Older People

Newark, Nottinghamshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for people with dementia

Participants were included in the study if they had:

  • A clinical diagnosis of dementia (any type)
  • A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).
  • Ability to give informed consent

Inclusion criteria

for caregiver of person with dementia

Participants were included in the study if they:

  • Cared for someone with a clinical diagnosis of dementia (any type)
  • Were paid or unpaid and regularly supported them with activities of daily living
  • Aged 18+ (no maximum age limit)
  • Able to give informed consent

Exclusion criteria

Exclusion criteria

for people with dementia

Participants were excluded if they:

  • Were already receiving psychotherapy
  • Had insufficient English or language abilities to engage in therapy
  • Were unable to consent to and/or engage in therapy

Exclusion criteria

for caregiver of person with dementia

Participants were excluded if they:

  • Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
  • Were unable to consent to and/or engage in study

Treatment and study plan

Acceptance and Commitment Therapy

Other

There is no specific protocol for ACT with dementia, therefore a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention.

Primary outcomes

  1. Change in anxiety

    Time frame: Through study completion, up to 24 weeks

    Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.

  2. Change in depression

    Time frame: Through study completion, up to 24 weeks

    Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.

Secondary outcomes

  1. Change in psychological flexibility

    Time frame: Through study completion, up to 24 weeks

    Comprehensive assessment of Acceptance & Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.

  2. Change in wellbeing

    Time frame: Through study completion, up to 24 weeks

    Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.

  3. Change in client problems

    Time frame: Through study completion, up to 24 weeks

    Personal questionnaire (PQ), where higher scores indicate greater severity of problems.

  4. Change in therapeutic alliance

    Time frame: Through study completion, up to 12 weeks

    Session rating scale (SRS), does not involve numerical values but asks clients to mark on a line nearest to the description that best fits their experience (marks further towards the right indicate better therapeutic alliance).

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Nottinghamshire Healthcare NHS Trust

Registry information

Official study title

Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 16, 2020
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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